Head and Neck Microvascular Free Flap, Reconstructive Surgery
Conditions
Brief summary
The aim of our study is to assess if patients undergoing head and neck free flap reconstructive surgery admitted to the ICU have equivalent postoperative outcomes to those admitted to an Otolaryngology specialty ward
Detailed description
Reconstruction with microvascular free flaps has become the standard of care for various surgical defects in head and neck region. Free flap reconstructive surgery is considered a major surgery with long intraoperative time and critical post-operative care. Close monitoring of the flap viability is of utmost importance especially in the first 48-72 hours after surgery, during which most of the vascular complications could occur; this interval is also critical for eventual successful salvage of an ischemic flap. Despite the delicacy of the matter worldwide there's not yet consensus about which is the most appropriate protocol for postoperative management after free flap surgery. Many patients undergoing free flap surgery are initially admitted to intensive care unit (ICU), even in cases of patients that do not meet any specific indication supporting the need for admission to an ICU setting. There are several reasons to this behaviour but, unfortunately, a post-operative stay in ICU is associated with increased nosocomial infections, complications and costs. The primary aim of this study will be to assess safety and postoperative outcomes (major and minor complications, flap failure rates and length of hospital stay) of patients undergoing reconstructive surgery with microvascular free flaps admitted to ICU compared to a non-ICU ward.The primary objective is to identify in which group of patients minor complications are more frequently encountered (complications that do not require surgical treatment in the operating room are considered as minor).
Interventions
PROCEDUREfree flap surgery
evaluation of major and minor complications, flap failure rates and length of hospital stay in patients undergoing free flap surgery admitted to intensive care unit and in those admitted to an Otolaryngology specialty ward
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patients undergoing Head and Neck oncological demolitive surgery and reconstruction using free or pedicled flaps at the Fondazione IRCCS Policlinico San Matteo, Pavia
Exclusion criteria
* patients treated for Head and Neck cancer without flap reconstruction (e.g., only chemotherapy-radiotherapy, only radiotherapy, only immunotherapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference in proportions of minor complications in the two groups of patients | up to 24 months | the difference in proportions of minor complications in the two groups of patients (ICU compared to a nonICU ward) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference in proportions of major complications and necrosis in the two groups of patients | up to 24 months | the difference in proportions of major complications and necrosis in the two groups of patients (ICU compared to a nonICU ward). |
| difference in length of hospitalisation in the two groups of patients | up to 24 months | the difference in length of hospitalisation in the two groups of patients (ICU compared to a non ICU ward) |
Countries
Italy
Contacts
Primary ContactSimone Mauramati
Outcome results
None listed